HMB + Vitamin D3 for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety, ease of use, and effects of a daily supplement combination of HMB (a compound that may aid muscle growth) and Vitamin D3 for adolescents with cerebral palsy. The researchers aim to determine if these supplements can improve muscle mass, strength, and movement over a 12-week period. Teens aged 13-17 with cerebral palsy who can walk and live near the University of Minnesota might be suitable candidates for this study. Participants should also be able to follow instructions, such as taking pills daily. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance the quality of life for adolescents with cerebral palsy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have prescription drug or nutrition supplement contraindications (reasons not to take them together), you may not be eligible to participate.
Is there any evidence suggesting that the HMB + Vitamin D3 supplementation is safe for adolescents with cerebral palsy?
Research has shown that taking HMB in doses of 1.5 to 3 grams per day is safe for humans for at least one year. The study uses a dose of 3 grams per day, which falls within this safe range. Most reports mention only mild side effects, such as stomach discomfort, and some studies have found no negative effects at all.
Vitamin D3 is usually well-tolerated, especially at the study's dose of 1000 IU per day. This amount is commonly found in supplements and is considered safe for most people.
Overall, existing research suggests that the combination of HMB and Vitamin D3 is expected to be safe. However, monitoring for any side effects and discussing any concerns with the research team or a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about using HMB and Vitamin D3 for cerebral palsy because this combination focuses on muscle health and bone strength, which are crucial for individuals with this condition. Unlike traditional treatments that might center on managing symptoms through physical therapy or medications, HMB (a compound that helps reduce muscle breakdown) and Vitamin D3 (essential for bone health) offer a novel approach by potentially enhancing physical capabilities directly. The convenience of a tablet format also makes it easy to administer, ensuring consistent dosing.
What evidence suggests that HMB + Vitamin D3 might be an effective treatment for cerebral palsy?
Research has shown that HMB, a compound that helps build muscle, and Vitamin D3 may improve muscle mass and strength. Studies have found that HMB increases muscle size and strength in both young and older adults. Vitamin D3 supports muscle function and maintains bone health. Although specific data for people with cerebral palsy is limited, this trial will evaluate the combined effects of HMB and Vitamin D3 supplements on muscle improvement in this population, drawing on their effects in other groups.12678
Are You a Good Fit for This Trial?
Adolescents aged 13-17 with cerebral palsy, specifically those who are ambulatory (GMFCS Level I-III) and can follow directions including taking pills daily. They should live near the University of Minnesota, read English, and not be pregnant or planning to become pregnant. Excluded if they've had recent surgeries or certain treatments that affect muscle strength.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily combined HMB + Vitamin D3 supplementation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HMB
- Vitamin D3
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gillette Children's Specialty Healthcare
Lead Sponsor
University of Minnesota
Collaborator
Metabolic Technologies, LLC
Collaborator